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EnSite X EP System, AutoMark Index Software License - EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01)
FDA 510(k)Class II (US FDA 510(k))
510(k) K251463
Identifiers
- 510(k) Number
- K251463 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
- Models / Variants
- EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EnSite X EP System, AutoMark Index Software License - EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01) by Abbott Medical — Class II…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251463 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA 510(k) K251463 24 fields · synced Jun 19, 2026